Fatty Liver DiseasePhase 1NCT07214870
A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
A Phase 1 study testing NNC4005-001 in people with Fatty Liver Disease, run by Novo Nordisk A/S at 1 site in Canada.
Trial summary
The purpose of this clinical study is to find out if NNC4005-0001 is well-tolerated and safe for people who have increased body weight and increased liver fat. Participants will receive either NNC4005-0001, which is the treatment being tested, or a placebo, which is a treatment that contains no active medicine. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Fatty Liver Disease
- What is being tested?
- NNC4005-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 8 Oct 2025to 14 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-69 years (both inclusive) at the time of signing the informed consent.
- Body Mass Index (BMI) of 27.0-40.0 kilogram per square meter (kg/m^2) (both inclusive) at screening process.
- Hepatic fat fraction greater than or equal to (≥) 8% by magnetic resonance imaging proton density fat fraction (MRI-PDFF) within 17 days prior to dosing.
- No prior or present clinical history of metabolic dysfunction-associated steatohepatitis (MASH) diagnosis.
Who cannot join
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Previous or current use of therapies for MASH or antifibrotic therapies (authorised or within aclinical trial).
- Use of high-dose vitamin E [greater than (>) 800 international unit (IU) per day], glucagon-like peptide-1 (GLP-1) agonists (such as liraglutide, dulaglutide, or semaglutide), glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 agonists (such as tirzepatide), or pioglitazone within 6 months prior to screening.
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels greater than or equal (≥) 1.5× Upper Limit of Normal (ULN) at screening.
- Total bilirubin levels > 1.5 times ULN if direct bilirubin is within Normal Limits (WNL) at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NNC4005-0001 in Adults
The purpose of this clinical study is to find out if NNC4005-0001 is well-tolerated and safe for people who have increased body weight and increased liver fat. Participants will receive either NNC4005-0001, which is the treatment being tested, or a placebo, which is a treatment that contains no active medicine. The study will last for about for about 7 to 8 months.
- Conditions
- Fatty Liver Disease
- Being tested
- NNC4005-001, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC4005-001Drug
NNC4005-0001 will be given as a single ascending dose via subcutaneous route
PlaceboDrug
Placebo matched to NNC4005-0001 will be given via subcutaneous route
| Study group | Role | What they receive |
|---|---|---|
| NNC4005-0001 | Experimental | Participants will receive a single dose of NNC4005-0001 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts. Receives: Drug: NNC4005-001 |
| Placebo | Placebo comparator | Participants in each cohort will receive placebo matched to NNC4005-0001 injected subcutaneously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent adverse event (TEAEs)
Measured as count of events
Measured: From dosing (day 1) until compeletion of end of study (EOS) visit on day 169
Secondary outcomes (5)
AUC(0-last): The area under the NNC4005-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose
microgram*hour per milliliter (μg*h/mL)
Measured: From dosing (day 1) to 48 hours post-dose
Cmax: The maximum concentration of NNC4005-0001 in plasma
Measured in microgram per millilitre
Measured: From dosing (day 1) to 48 hours post-dose
tmax: The time from dose administration to the maximum plasma concentration of NNC4005-0001
Hour
Measured: From dosing (day 1) to 48 hours post-dose
t1/2: Half life
Hour
Measured: From dosing (day 1) to 48 hours post-dose
CLr: Renal clearance
Liter/hour (L/h)
Measured: From dosing (day 1) to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start8 Oct 2025
- Primary completion14 May 2027 (estimated)
- Study completion14 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency' (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214870
- Sponsor's protocol ID
- NN4005-8221
- Other IDs
- UTN
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NNC4005-0001 in Adults
- ClinicalTrials.gov ID
- NCT07214870
- Acronym / sponsor ID
- NN4005-8221
- Conditions
- Fatty Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 14 May 2027 (estimated)
- Study completion
- 14 May 2027 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to find out if NNC4005-0001 is well-tolerated and safe for people who have increased body weight and increased liver fat. Participants will receive either NNC4005-0001, which is the treatment being tested, or a placebo, which is a treatment that contains no active medicine. The study will last for about for about 7 to 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC4005-0001 | Experimental | Drug: NNC4005-001Participants will receive a single dose of NNC4005-0001 injected subcutaneously. Trial will include up to 6 ascending single-dose cohorts. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in each cohort will receive placebo matched to NNC4005-0001 injected subcutaneously. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-69 years (both inclusive) at the time of signing the informed consent.
- Body Mass Index (BMI) of 27.0-40.0 kilogram per square meter (kg/m^2) (both inclusive) at screening process.
- Hepatic fat fraction greater than or equal to (≥) 8% by magnetic resonance imaging proton density fat fraction (MRI-PDFF) within 17 days prior to dosing.
- No prior or present clinical history of metabolic dysfunction-associated steatohepatitis (MASH) diagnosis.
Key exclusion criteria (5 listed)
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Previous or current use of therapies for MASH or antifibrotic therapies (authorised or within aclinical trial).
- Use of high-dose vitamin E [greater than (>) 800 international unit (IU) per day], glucagon-like peptide-1 (GLP-1) agonists (such as liraglutide, dulaglutide, or semaglutide), glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 agonists (such as tirzepatide), or pioglitazone within 6 months prior to screening.
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels greater than or equal (≥) 1.5× Upper Limit of Normal (ULN) at screening.
- Total bilirubin levels > 1.5 times ULN if direct bilirubin is within Normal Limits (WNL) at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC4005-001NNC4005-0001 will be given as a single ascending dose via subcutaneous route | Drug | NNC4005-0001 |
| PlaceboPlacebo matched to NNC4005-0001 will be given via subcutaneous route | Drug | Placebo |
Primary outcome
Number of Treatment-emergent adverse event (TEAEs)
Time frame: From dosing (day 1) until compeletion of end of study (EOS) visit on day 169
Measured as count of events
5 secondary outcomes
AUC(0-last): The area under the NNC4005-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose
Time frame: From dosing (day 1) to 48 hours post-dose
Cmax: The maximum concentration of NNC4005-0001 in plasma
Time frame: From dosing (day 1) to 48 hours post-dose
tmax: The time from dose administration to the maximum plasma concentration of NNC4005-0001
Time frame: From dosing (day 1) to 48 hours post-dose
t1/2: Half life
Time frame: From dosing (day 1) to 48 hours post-dose
CLr: Renal clearance
Time frame: From dosing (day 1) to 48 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency' (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC4005-001 in people with Fatty Liver Disease, run by Novo Nordisk A/S at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-emergent adverse event (TEAEs) (time frame: From dosing (day 1) until compeletion of end of study (EOS) visit on day 169). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.